Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty

• Sponsor: Rothman Institute Orthopaedics (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04590742
• Collaborator: (none)
• Enrollment: 154
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 45.1
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty

Condition or Disease	Intervention/Treatment	Phase
Sleep Disturbance; Total Joint Arthroplasty	Drug: melatonin 6mg; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty
• Actual Study Start Date: Feb 27, 2018
• Anticipated Primary Completion Date: Nov 30, 2021
• Anticipated Study Completion Date: Nov 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group 1 Placebo Tablet	Drug: Placebo; Patient given 6 weeks of placebo tablet
Active Comparator: Group 2 Melatonin (6mg)	Drug: melatonin 6mg; 6 weeks of melatonin (6mg) given to patient

Outcome Measures

Primary Outcome Measures

1. Patient Sleep Quality [6 weeks]

   Patients quality of sleep will be analyzed by having them answer a sleep quality index (PSQI) questionnaires

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Patients who undergo unilateral primary total joint arthroplasty

2. Patient willing and able to complete postoperative surveys

Exclusion Criteria:

1. Patients who undergo revision total joint arthroplasty

2. Patients who undergo bilateral total joint arthroplasty

3. Patients currently taking melatonin supplementation

4. Patient has history of substance abuse (drug or alcohol)

5. Patient is a workman's comp patient or patient has current litigation pending

6. Patient has an allergy to melatonin

7. Patient has a history of delirium/psychiatric/depression/on antidepressants

8. Patient has a history of insomnia/ on sleep aid medication

9. Anyone on warfarin

10. Sleep apnea

11. Patient discharged to SNF or rehab

12. Patients who have inflammatory conditions

13. Shift work or night work

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT04590742
• Other Study ID Numbers: JJP17D.511
• First Posted: Oct 19, 2020
• Last Update Posted: Oct 19, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dyssomnias; Parasomnias; Melatonin

Study Results

No Results Posted as of Oct 19, 2020